(262 days)
The AbbVie NJ is intended to provide short-term enteral access for administration of medication to the small intestine.
The AbbVie™ NJ is a 10 FR, 152 cm, naso-jejunal (NJ) tube made of white radiopaque polyurethane. The distal coiled end region and bolus tip are coated with a water activated lubricant. The AbbVie NJ includes a silicone coated Stylet.
This document describes the pre-market notification for the AbbVie™ NJ device, a naso-jejunal tube. It explicitly states that "No clinical evaluations were performed or relied upon for the determination of substantial equivalence." This means that the device's performance was assessed through non-clinical data and comparison to a predicate device, rather than through a clinical study that would generate the kind of data you're asking for regarding acceptance criteria, sample sizes, and expert review.
Therefore, I cannot provide the requested information, including a table of acceptance criteria and reported device performance based on a human study, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or details about training sets.
The relevant information from the document is as follows:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical):
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Biocompatibility: Conformance to ISO 10993-1:2009 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process. | The material composition of the AbbVie NJ shows acceptable performance across all biocompatibility protocols tested per ISO 10993-1:2009. |
| Enteral Feeding Catheters and Giving Sets: Conformance to BS EN 1615:2000 Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing. | An assessment of the AbbVie NJ has been completed and shown to be acceptable per BS EN 1615:2000. |
| Small-bore Connectors: Conformance to ISO 80369-1:2010 Small-bore Connectors for Liquids and Gases in Healthcare Applications- Part 1: General requirements. | An assessment of the AbbVie NJ has been completed and shown to be acceptable per ISO 80369-1:2010. |
| Substantial Equivalence to Predicate Device (Entriflex™ Feeding Tube, K833621): No differences that would affect safety or effectiveness, and no new issues of safety or effectiveness are raised. | The AbbVie NJ is substantially equivalent to the currently marketed predicate device, Entriflex Feeding Tube (K833621). Both devices are naso-enteric tubes with the same fundamental structure and function. The AbbVie NJ tube diameter (10 FR) falls within the predicate's range. Duration of use (30 days or less), stylet feature, tube material (polyurethane), and anatomical delivery are the same. Differences (tube length, distal end, proximal connector, sterility) do not raise new issues of safety or effectiveness. The indication for use (administration of medication) is within the predicate's indications. |
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (tube), not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical device (tube).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical studies, conformance to established industry standards and substantial equivalence to a legally marketed predicate device.
8. The sample size for the training set: Not applicable. No clinical training set.
9. How the ground truth for the training set was established: Not applicable. No clinical training set.
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K133129 Page 1 of 3
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| abbvie | AbbVie NJ K133129 |
|---|---|
| Traditional 510(k) Notification | |
| 510(k) Summary |
510(k) Summary
Sponsor:
AbbVie Inc. 1 N. Waukegan Road North Chicago, IL 60064
Contact:
Katherine Wortley, Ph.D. Director Regulatory Affairs AbbVie Inc. Telephone: (847) 938-7707 Fax: (847) 775-4997 Email: katherine.wortley@abbvie.com
Date Prepared:
September 30, 2013
Device:
| Trade Name: | AbbVie™ NJ |
|---|---|
| Common Name: | Naso-Jejunal Tube |
| Classification: | Tubes, Gastrointestinal and Accessories |
| Name: | 21 CFR 876.5980, Product Code KNT, Class II |
Entriflex™ Feeding Tube, K833621 Predicate Device:
Device Description:
The AbbVie™ NJ is a 10 FR, 152 cm, naso-jejunal (NJ) tube made of white radiopaque polyurethane. The distal coiled end region and bolus tip are coated with a water activated lubricant. The AbbVie NJ includes a silicone coated Stylet.
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AbbVie NJ K133129 abbvie Traditional 510(k) Notification 510(k) Summary
Device Intended Use:
The AbbVie NJ is intended to provide short-term enteral access for administration of medication to the small intestine.
Comparison of Product Characteristics:
The AbbVie NJ is substantially equivalent to the currently marketed predicate device, Entriflex Feeding Tube (K833621). Both devices are naso-enteric tubes. The tubes have the same fundamental structure and function. The predicate is a family of devices that vary in diameter (8, 10, and 12 FR) and length. The AbbVie NJ tube diameter (10 FR) falls within the range of the Entriflex product family. Duration of use (30 days or less), stylet feature, tube material (polyurethane), and anatomical delivery (through the nose into the small intestine) are the same as the predicate. Differences include tube length, distal end configuration, proximal end connector type, and sterility status. The indication for use for the AbbVie NJ (administration of medication) is within the indications for use of the Entriflex Feeding Tube (administration of feeding, fluid and medication).
Non-Clinical Performance Data:
The performance characteristics of the AbbVie NJ have been verified based on the conformance to applicable industry standards. The material composition of the Abb Vie NJ shows acceptable performance across all biocompatibility protocols tested per ISO 10993-1:2009 Biological evaluation of medical devices-Part 1: Evaluation und testing within a risk management process. The AbbVic NJ was assessed for conformance to standard BS EN 1615:2000 Enteral feeding catheters and enterul giving sets for single use and their connectors - Design and testing. An assessment of the AbbVie NJ has been completed and shown to be acceptable per ISO 80369-1:2010 Small-bore Connectors for Liquids and Gases in Healthcare Applications- Part 1: General requirements.
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AbbVic NJ K133129 abbvie Traditional 510(k) Notification 510(k) Summary
Clinical Performance Data:
No clinical evaluations were performed or relied upon for the determination of substantial equivalence.
Conclusion:
The information provided within this pre-market notification demonstrates that the AbbVie NJ has no differences that would affect the safety or effectiveness of the device as compared to the predicate device, Entriflex Feeding Tube. The differences between the two devices do not raise new issues of safety or effectiveness. The AbbVie NJ is substantially equivalent to the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2014
AbbVie, Inc. Katherine Wortley, Ph.D., RAC Director Regulatory Affairs 1 N. Waukegan Road North Chicago, IL 60064
Re: K133129
Trade/Device Name: AbbVie™ NJ Regulation Number: 21 CFR 8 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: May 15, 2014 Received: May 16, 2014
Dear Katherine Wortley,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r case ve actised that I Bromination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 - Katherine Wortley, Ph.D., RAC
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -A
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K133129
Device Name: AbbVie™ NJ
Indications for Use:
The AbbVie NJ is intended to provide short-term enteral access for administration of medication to the small intestine.
Prescription Use X
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lern 2014.06.19 1
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.